A group-randomized and controlled trial is proposed in 24 primary care clinics located in St. Paul, Minnesota and the surrounding communities to evaluate a highly developed multifaceted diabetes-specific intervention, The broad goal of the study is to successfully translate empirical knowledge regarding diabetes treatment and management into sustainable clinical practice. The focus is on the primary care environment, where the majority of patients with diabetes seek on-going health care. The clinical trial evaluates the effectiveness of the TRANSLATE intervention multifaceted diabetes intervention program promoting better comprehensive diabetes management. The intervention begins by evaluating the organizational structures of primary care offices and identifying existing barriers in these small complex systems. A set of nine well-developed intervention components selected from among some of the most successful strategies in the literature for altering clinical outcomes are then introduced to correct existing deficiencies at each clinic. The TRANSLATE components function as an interdependent system, providing substantial support to both the provider and patient. Key features include the targeting of high-risk patients, a patient reminder system for routine visits, both passive and patient-specific physician reminders, a disease-specific networked reporting system, and physician education. Implementation is facilitated by a local diabetes intervention team assisted by a site coordinator and a local physician champion. Notably, the model does not centralize care, but rather promotes dissemination of care delivery improvements by promoting infrastructure changes at the primary care clinic where most care is delivered. Quality improvement methods are employed to optimize implementation in each unique clinic setting. Upper level administrative personnel are integrated into the regular review of implementation measures and resource use. The study evaluates average A1c and systolic blood pressure values for over 6,400 diabetes patients in control and intervention clinics. In addition, the study implements widely used diabetes performance measures to evaluate the quality of health care delivery. Finally, short and long term cost of the intervention is evaluated from the perspective of the health system. The intervention was developed by a strong collaborative group of primary care physicians, endocrinologists, managed care organizations, and health care purchasers, and has been pilot tested in nine clinics where substantial improvement in average A1c levels and in disease process measures have been demonstrated.